What do you need to fulfill the clinical requirements of the medical devices in China?

Ask yourself these three questions to define the clinical strategy for your products in China:

• Does my product require a local clinical trial?

• Is my product covered within the scope of the clinical evaluation exemption?

• What are the options if my product is not exempted from clinical trial or clinical evaluation?

My previous post elaborated on the criteria the product must fulfill to be clinically exempt.

For this post, I will cover the eligibility assessment of the clinical evaluation exemption.

🍜 What products are exempt?

China’s NMPA published “Guidance on the Product Comparison Analysis for the Medical Device covered under the Catalogue of Clinical Evaluation Exemption” in 2021.

You can check whether your product is listed in the List of Medical Devices Exempt from Clinical Evaluation (2025 version). 

You can easily search whether your product is included by pasting your Chinese product classification code (Format: xx-xx-xx).

For example, Image Analyzer has a product code of 22-07-03.

The exemption list only covers Class II and Class III medical devices.

The filing of Class I medical devices does not require the submission of clinical data.

🍜 What if your product is exempt?

Then, you just need to prepare a simpler version of the clinical evaluation.

A comparison assessment to compare your product to the identical or similar products that have acquired marketing approval in China.

The supporting documents shall be supplemented together with the assessment table.

Click here to download the comparison template in English for your analysis.

The following criteria must be taken into account for the assessment:

• Have identical or similar medical devices been approved in China?

  It does not matter whether the product has been registered by domestic or foreign manufacturers. Keep searching!

  The medical device can be used as a predicate as long as it can be found in the NMPA database.

• What are the differences between your product and the chosen predicate(s) in terms of the safety and efficiency of the product? 

  You can use multiple medical devices for comparison if one doesn’t cover all the aspects.

  The comparison criteria include, but are not limited to the following:

  1. Working principle/ mechanism of action

  2. Structural composition

  3. Materials used and/or materials in contact with human

  4. Performance requirements

  5. Sterilization or disinfection methods

  6. Intended use

  7. Method of operation

  8. Other relevant criteria based on product type and characteristics

❗Note: Your product must not introduce risks or issues that were absent in the predicate product, especially those that may lead to significant risks and/or problems that highly affect the effectiveness.

The principle from Hippocratic Oath reminds us…

The submitted comparison data should demonstrate that your product and the predicate product listed in the Product List are equivalent.

If your product is not fundamentally equivalent to the product described in the Product List, a clinical evaluation shall be performed instead.

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Disclaimer: This content is created solely in my personal interest and does not reflect the views, opinions, or policies of my employer or any other organizations I am affiliated with. Neither I nor my employer is liable for any use of this content. This newsletter does not compete with my employer’s interests. Any references to regulatory updates or guidance are based on publicly available information and are not intended to infringe upon proprietary or confidential content.